Embedded Expertise: Pioneering a Radiopharmaceutical Services Model

The Scenario

CytoSiteBio (CytoSite), a biotech company developing a novel diagnostic radiopharmaceutical—a Granzyme B imaging agent—sought to evaluate its potential as a companion diagnostic in immuno-oncology. The company recognized the agent’s significant scalability and potential for applications beyond its original purpose. To achieve this, CytoSite required expert guidance to navigate the complex regulatory, clinical, and business challenges associated with this emerging field.

The Challenge

CytoSite faced several multifaceted challenges in advancing its novel diagnostic radiopharmaceutical:

• Clinical Development: Creating a protocol tailored to immuno-oncology applications while ensuring sustainable scalability.
• Regulatory Compliance: Successfully navigating strict regulatory pathways to meet evolving requirements.
• Market Positioning: Strategically positioning the imaging agent to attract interest from biotech and pharmaceutical companies exploring new therapeutic landscapes.
  
  

The Strategy

To address these challenges, CytoSite engaged the Bracken team, leveraging our extensive expertise in radiopharmaceuticals, clinical trial design, regulatory affairs, and business development. Bracken’s integrated approach enabled CytoSite to meet its objectives efficiently and effectively.

Our collaboration focused on three critical areas:

1. Protocol Development and Clinical Leadership: Bracken was an intrinsic partner to CytoSite during the early stages of protocol design, ensuring alignment with regulatory guidelines and the agent’s intended clinical applications. This approach led to the development of a trial methodology tailored to both scientific and regulatory demands.
2. Radiopharmaceutical Services Model: Bracken designed a scalable services model for the production, distribution, and clinical use of the Granzyme B imaging agent. This model streamlined operations, reduced logistical complexity, and addressed the unique requirements of diagnostic radiopharmaceuticals.
3. Regulatory and Business Development Support: Our team provided ongoing regulatory expertise to navigate compliance challenges effectively. Additionally, we supported CytoSite’s business development efforts by positioning the imaging agent as a versatile tool for immuno-oncology, attracting interest from pharmaceutical and biotech companies developing novel therapies.

The Results

Bracken’s involvement transformed CytoSite’s approach, delivering key results:

• A robust clinical trial protocol was established, setting the stage for regulatory approval.
• A scalable services model enabled CytoSite to manage the complex logistics of radiopharmaceuticals efficiently.
• The Granzyme B imaging agent became a sought-after diagnostic tool in immuno-oncology, extending its utility beyond CytoSite’s internal pipeline to other companies developing new therapies.
• Following the success of this initial project, Bracken’s team has worked with CytoSite on a repeated, regular basis—becoming trusted partners, team members, and collaborators.

Bracken’s intrinsic, dedicated partnership with CytoSite on this initial project exemplifies how interdepartmental, integrated expertise in clinical, regulatory, and operational areas can accelerate the development and scalability of innovative technologies and solutions.

Through an embedded, collaborative approach throughout every aspect of the process, Bracken ensured the Granzyme B imaging agent was positioned for success, transforming its role from a promising diagnostic tool to a cornerstone of immuno-oncology diagnostics.

Click here to open a PDF version of this case study.